Clinical Evidence & Lifecycle Strategy
Clarify the evidence decision before gaps threaten approval, intended claims, or product continuity.
Clinical evidence is not only a study question. It determines what the organization can claim, what regulators can accept, and what the business must continue to support throughout the device lifecycle.
SHOTUNE provides founder-led clinical evidence advisory for Class I–III medical device companies facing FDA, EU MDR, Notified Body review, renewal, remediation, and post-market scrutiny. The work helps leadership understand what the evidence can support, where the exposure remains, and which next step is proportionate to the decision.
Request an EU MDR Readiness Review
A private first conversation to understand the evidence decision, locate the connected exposure, and determine whether SHOTUNE is the right fit.
The decision context
The evidence plan changes more than whether another study is needed.
It affects the claims the organisation can defend, the strength of the benefit-risk position, approval durability, PMCF and PMS obligations, technical-documentation integrity, and review timing. Leadership needs those consequences visible together before clinical activity becomes a collection of disconnected requirements.
Claims and benefit-risk
Determine whether the available evidence supports the intended use, indications, claims, and benefit-risk position the organization must defend.
Approval durability
Keep the evidence position coherent as the device, indications, markets, claims, and regulatory obligations change over time.
Post-market readiness
Connect CER, CEP, PMCF, PMS, risk management, and post-market signals so they address the same clinical questions.
Evidence proportionality
Separate necessary evidence from activity that adds delay or operational burden without resolving the clinical question under pressure.
When to escalate
Escalate when the evidence question begins changing approval, claims, renewal, or lifecycle decisions.
Senior clinical judgment becomes especially important when the existing evidence no longer supports one clear position, study activity is expanding without resolving the gap, or post-market obligations are being considered separately from the approval and claims strategy.
- The available evidence and intended claims no longer support the same position.
- CER, CEP, PMCF, PMS, risk management, and benefit-risk conclusions are not aligned.
- Studies are underway, but the decision they are meant to support is no longer clear.
- Leadership must decide whether more evidence is necessary, avoidable, poorly timed, or directed at the wrong clinical question.
- Evidence uncertainty is beginning to affect approval timing, market access, lifecycle burden, or portfolio confidence.
Strategic scope
Where SHOTUNE brings the clinical evidence decision back into view.
The work connects evidence strategy, intended claims, regulatory expectations, benefit-risk reasoning, and lifecycle obligations so leadership can determine what remains usable, what must be strengthened, and what should happen next.
Integrated evidence strategy
Align CER, CEP, PMCF, PMS, and clinical evidence planning with the regulatory pathway, intended use, claims, device lifecycle, and post-market obligations.
Evidence-gap assessment
Evaluate the current evidence position and identify where data, documentation, claims, benefit-risk conclusions, or regulator expectations no longer align.
Proportionality and study architecture
Determine what evidence is proportionate to the regulatory and clinical decision and how study activity should be structured around the question that actually needs resolution.
Claims, risk, and lifecycle alignment
Connect claims support and benefit-risk reasoning to lifecycle evidence planning, post-market surveillance, and the obligations the organization must continue to carry.
The integrated evidence position
A defensible evidence position requires regulatory, risk, quality, post-market, and technical-documentation logic to agree.
Clinical evidence becomes fragile when each function is working from a different version of the indication, claim, risk, or lifecycle obligation. SHOTUNE helps leadership identify where those positions diverge and which decision must be resolved before additional work proceeds.
Regulatory strategy
The evidence plan supports the pathway, intended use, claims, and decisions presented to regulators.
Claims
The available data, intended indications, labelling, external claims, and technical documentation remain within one supportable position.
Risk management
Benefit-risk conclusions, clinical evidence, known hazards, and residual uncertainty tell one coherent story.
Quality systems
Clinical and post-market obligations connect to the quality processes responsible for collecting, evaluating, documenting, and acting on the evidence.
Submission timing
Evidence decisions remain connected to approval timing, renewal timing, technical-documentation dependencies, product priorities, and lifecycle obligations.
How SHOTUNE works
Founder-led advisory focused on the evidence decision, not study volume.
SHOTUNE begins with the decision the evidence must support. Dr. Shola Sulaimon reviews the available data, intended use, claims, benefit-risk rationale, regulatory context, existing clinical documentation, and lifecycle obligations.
The work then clarifies what the evidence can support, where the material gaps remain, and which next steps are proportionate to the approval, claims, or lifecycle decision in front of leadership.
Define the decision the evidence must support
Clarify the approval, intended-use, claims, benefit-risk, post-market, or lifecycle decision leadership needs to make.
Evaluate the current evidence position
Review the available data, intended claims, CER, CEP, PMCF, PMS, benefit-risk logic, post-market signals, and unresolved uncertainty.
Map the gaps and connected consequences
Identify where evidence, claims, risk conclusions, regulatory expectations, quality processes, timing, or lifecycle obligations no longer align.
Set proportionate priorities and ownership
Translate the assessment into the next evidence decisions, responsible owners, required work, and a practical sequence for moving forward.
Founder accountability
Senior clinical judgment remains close to the evidence without assuming every uncertainty requires another study.
Every clinical evidence engagement is led directly by Dr. Shola Sulaimon. She works with leadership and technical teams to examine what the evidence supports, challenge the assumptions behind the current position, and connect the clinical question to its regulatory, quality, risk, post-market, technical-documentation, and lifecycle consequences.
The objective is a coherent and proportionate evidence position that leadership understands, technical teams can carry forward, and the organization can defend through submission, regulator review, audit, external review, and post-market execution.
Frequently asked questions
Questions leadership often brings into the first conversation.
How does SHOTUNE design clinical evidence strategy for FDA and EU MDR expectations?
SHOTUNE starts with the decisions the evidence must support. The review considers the regulatory pathway, intended use, intended claims, benefit-risk position, existing evidence, post-market obligations, and technical-documentation context before recommending additional work.
The scope depends on the device, development stage, intended markets, claims, regulatory history, and evidence already available.
Our existing evidence does not clearly support our intended claims. Can SHOTUNE help?
Yes. The first task is to determine whether the problem is a true evidence gap, a claim that exceeds the available support, a documentation weakness, or a broader misalignment across clinical, regulatory, quality, and risk logic.
That distinction determines whether the next step involves new evidence, revised claims, improved documentation, or a different regulatory and clinical strategy.
Can SHOTUNE support clinical programs that are already underway or poorly aligned?
Yes. SHOTUNE can review what the existing data and study activity can support, identify the assumptions driving the current program, and determine where the plan no longer fits the regulatory, claims, benefit-risk, or lifecycle decision.
The objective is to preserve usable work while identifying what requires correction, redirection, or additional support.
How does SHOTUNE respond when a Notified Body challenges the CER, PMCF, or technical documentation?
A challenge to the CER, PMCF, or technical documentation may reflect a weakness in the underlying evidence position rather than a wording problem alone.
SHOTUNE reviews how the evidence, claims, benefit-risk rationale, risk management, post-market plan, and regulatory strategy fit together, then helps leadership identify which decision or gap must be addressed first.
Does SHOTUNE support PMS and PMCF strategy?
Yes. PMS and PMCF should remain connected to the intended claims, risk profile, clinical questions, regulatory commitments, and lifecycle decisions they are meant to support.
SHOTUNE helps leadership assess whether the post-market plan is proportionate, whether it addresses the material uncertainty, and whether it remains aligned with the broader evidence position.
How is clinical evidence integrated with quality and risk management?
Clinical evidence, claims, risk management, quality controls, complaints, vigilance, PMS, and PMCF should support the same product position.
SHOTUNE helps leadership identify where those elements diverge and what must be realigned so the organization can maintain one coherent rationale through the device lifecycle.
What outcome should leadership expect from an initial clinical evidence engagement?
The organization should leave with a clearer understanding of what the current evidence supports, which gaps are material, how those gaps affect claims, approval, risk, or lifecycle obligations, and what decisions or evidence activities should happen next.
The next step
Need clinical evidence clarity before the next study, submission, or lifecycle decision?
Bring the evidence gap, claims question, regulator concern, study plan, or post-market issue. The first conversation is used to understand the context, locate the connected exposure, and determine whether SHOTUNE is the right fit.
Request an EU MDR Readiness Review
One focused conversation to clarify the evidence decision, the exposure, and the next responsible step.